Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

NCT02172222 | Completed Phase 1

• 1 other identifier: 1245.30
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to day 8

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to day 8

Secondary Outcomes (9)

• tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state)

  up to day 8

• Urine glucose excretion (UGE)

  Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit

• Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition

  2 hours and 24 hours after last administration of study drug

• Changes from baseline in physical examination

  Baseline and within 5 days after last study drug administration

• Changes from baseline in vital signs (blood pressure, pulse rate)

  Baseline, day 1 and within 5 days after last study drug administration

Study Arms (2)

Sequence ABC

EXPERIMENTAL

1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI10773 and linagliptin once daily from day 1 to 7 3. Treatment C: Linagliptin once daily from day 1 to 7

Drug: BI 10773; Drug: Linagliptin

Sequence CAB

EXPERIMENTAL

1. Treatment C: Linagliptin once daily from day 1 to 7 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI10773 and linagliptin once daily from day 1 to 7

Drug: BI 10773; Drug: Linagliptin

Interventions

BI 10773 DRUG

Sequence ABC; Sequence CAB

Linagliptin DRUG

Sequence ABC; Sequence CAB

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers according to the following criteria:
• Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests
• Age 18 to 50 years (inclusive)
• BMI 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 30 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

empagliflozin; Linagliptin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06